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America's Most Admired Lawbreaker

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9

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Innovative

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Americans trust pharmaceutical companies to value consumer safety over corporate profits. And, when companies act illegally, Americans trust the government to pursue and punish the wrongdoers. But what if that trust is grossly misplaced? In this 15-part article, or “docuserial,” lawyer and journalist Steven Brill offers an in-depth account of how Johnson & Johnson knowingly and systematically violated US Food & Drug Administration restrictions when it marketed its antipsychotic drug Risperdal. Brill lays out detailed evidence showing exactly how and why the company decided to pursue “off-label” marketing of Risperdal. He asks if the court meted out adequate punishment and if its ruling really discourages such practices in the future. Noting that such stories have two sides and this is mostly one of them, getAbstract recommends this series to those interested in health care practices and regulation.

About the Author

Steven Brill is an American lawyer, journalist and recipient of multiple National Magazine Awards. Brill’s 2015 book, America’s Bitter Pill: Money, Politics, Backroom Deals, and the Fight to Fix Our Broken Healthcare System, was a New York Times bestseller.

Summary

The Rise of Risperdal

Johnson & Johnson (J&J) developed Risperdal to replace its antipsychotic drug Haldol, which by 1986 was no longer under patent protection. J&J sought to market Risperdal as a “step up” from Haldol. It also hoped to capture the broad market share that Haldol targeted as a treatment for a wide range of conditions, including dementia and Attention Deficit Disorder. However, the US Food & Drug Administration (FDA) did not approve J&J’s broad-uses pitch for Risperdal. Regulators found that J&J hadn’t provided proof that it was in any way superior to Haldol. Moreover, the FDA claimed J&J’s tests didn’t establish Risperdal’s safety or effectiveness in seniors and children or for any use except treating adult schizophrenia.

Circumventing the FDA

To meet its desired profit margins, J&J had to expand the sale of Risperdal beyond its label. To this end, J&J focused its marketing efforts on doctors – who aren’t required to follow FDA guidelines when they prescribe if they believe a given drug is the best course of treatment for a patient. Specifically, J&J wanted Risperdal to...